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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K153039
Device Name MRI Dynamic Analysis Plus
Applicant
Esaote, S.p.A.
Via Siffredi 58
Genova,  IT 16153
Applicant Contact DONATELLA RAGGHIANTI
Correspondent
Navigant Consulting, Inc.
9001 Wesleyan Rd.
Suite 200
Indianpolis,  IN  46268
Correspondent Contact ALLISON SCOTT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/19/2015
Decision Date 01/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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